LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Overview

Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.

Full Title of Study: “A Randomized, Controlled Trial of Lateral Lumbar Interbody Fusion Plus Posterior Decompression or Not for Severe Lumbar Spinal Stenosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2022

Detailed Description

The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.

Interventions

  • Procedure: Lateral lumbar interbody fusion
    • LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.

Arms, Groups and Cohorts

  • Experimental: Lateral lumbar interbody fusion
    • Patients in this group received lateral lumbar interbody fusion alone. Patients who suffered residual neurologic symptoms postoperatively will received conservative treatment for at least 3 months.Patients were considered to have unsuccessful indirect decompression if they had less than 20% improvement according to the Oswestry Disability Index (ODI) by 3 months postoperatively.
  • Experimental: Lateral lumbar interbody fusion plus posterior decompression
    • Patients in this group received lateral lumbar interbody fusion plus posterior decompression.

Clinical Trial Outcome Measures

Primary Measures

  • Oswestry Disability Index (ODI)
    • Time Frame: Preoperative, 3-month, 12-month,24-month after surgery
    • The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient’s permanent functional disability

Secondary Measures

  • Visual Analogue Scale (VAS)
    • Time Frame: Preoperative, 3-month, 12-month,24-month after surgery
    • The VAS is a self-report measure of the intensity of pain (score range 0 – 10 ). A higher score indicates greater pain intensity.
  • Zurich Claudication Questionnaire(ZCQ)
    • Time Frame: Preoperative, 3-month, 12-month,24-month after surgery
    • The ZCQ is a disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis.The result is expressed as a percentage of the maximum possible score (22.22% – 100%). The score increases with worsening disability.The The ZCQ consists of three subscales: symptom severity scale, physical function scale and patient’s satisfaction with treatment scale.

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female patients who are 50 – 80 years of age. – Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain. – Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment. – Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study. Exclusion Criteria:

  • Patients with lumbar pathologies requiring treatment at more than two levels. – Patients who have had previous lumbar fusion surgery. – Patients with congenital lumbar stenosis. – Patients with radiographic confirmation of Grade IV facet joint disease or degeneration. – Patients with noncontained or extruded herniated nucleus pulposus. – Patients with active local or systemic infection. – Patients with rheumatoid arthritis or other autoimmune disease. – Patients who cannot undergo magnetic resonance imaging (MRI). – Patients who are mentally incompetent. – Patients with BMI over 30kg/m2 or less than 18 kg/m2.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fangcai Li, MD, Principal Investigator, The Second Affiliated Hospital of Medical College Zhejiang University

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